Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 11:21 PM
Study NCT ID:
NCT04705532
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2021-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-09', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-back', 'timeFrame': 'It will be measured over the course of four weeks', 'description': 'The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from 3 steps earlier in the sequence.'}], 'secondaryOutcomes': [{'measure': 'Stroop', 'timeFrame': 'It will be measured over the course of four weeks', 'description': 'The subject has to name the font color of a printed word, while it can have a mismatch between the word and the color (ex: green is written in red).'}, {'measure': 'EEG - alpha power', 'timeFrame': 'It will be measured over the course of four weeks', 'description': 'Brain activity will be measured with an electroencephalography collected at rest. We will first look at the change in alpha power (8-12Hz)'}, {'measure': 'EEG - beta power', 'timeFrame': 'It will be measured over the course of four weeks', 'description': 'Brain activity will be measured with an electroencephalography collected at rest. We will also look at the change in other frequency bands (e.g., beta, theta, delta).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims at comparing the effects of transcranial direct current stimulation combined with music on neurophysiological outcomes in healthy participants. This study also aims to evaluate the effects of tDCS combined with music on cognition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults\n\nExclusion Criteria:\n\n* neurological disorders\n* psychiatric disorders\n* contra-indication to tDCS (eg, metallic brain implant, pacemaker)\n* pregnancy\n* alcool abuse\n* active smoker'}, 'identificationModule': {'nctId': 'NCT04705532', 'briefTitle': 'Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation', 'orgStudyIdInfo': {'id': '2014-280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS/music', 'description': 'active tDCS combined with music', 'interventionNames': ['Device: tDCS', 'Other: Music']}, {'type': 'EXPERIMENTAL', 'label': 'sham tDCS/music', 'description': 'Sham tDCS combined with music', 'interventionNames': ['Device: Sham tDCS', 'Other: Music']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS/white noise', 'description': 'active tDCS combined with white noise', 'interventionNames': ['Device: tDCS', 'Other: White noise']}, {'type': 'EXPERIMENTAL', 'label': 'sham tDCS/white noise', 'description': 'sham tDCS combined with white noise', 'interventionNames': ['Device: Sham tDCS', 'Other: White noise']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'Multi-channel tDCS will be applied over the executive network for 20 minutes at 4mA', 'armGroupLabels': ['tDCS/music', 'tDCS/white noise']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.', 'armGroupLabels': ['sham tDCS/music', 'sham tDCS/white noise']}, {'name': 'Music', 'type': 'OTHER', 'description': 'Subjects will listen to their preferred music for 20 minutes', 'armGroupLabels': ['sham tDCS/music', 'tDCS/music']}, {'name': 'White noise', 'type': 'OTHER', 'description': 'Subjects will listen to a white noise for 20 minutes', 'armGroupLabels': ['sham tDCS/white noise', 'tDCS/white noise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'University Hospital of Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aurore Thibaut', 'investigatorAffiliation': 'University of Liege'}}}}